1. they'd already licensed it, so the patent holders are already compromising 2.patents are really not that long..5yrs? 20 yrs? nothing like life+99 or whatever it is for copyright.. 3.because patents are relatively short lived the pharma firms have to turn up "hits" which have to pay for all the other misses.. i'm guessing they would really rather market+brand their existing products than invent new ones if the protection they get from patents start to get eroded..not sure thats a good thing..
How India's Patent Office Destroyed Gilead's Global Game Plan
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Re: How India's Patent Office Destroyed Gilead's Global Game Plan
#42According to Wikipedia: Sofosbuvir costs US$84,000 for 12 weeks of treatment used for genotypes 1 and 2 (about US$1,000 per pill) [...] health care costs in California could increase by US$18–29 billion per year because of this medication
Calculate the annual cost (which isn't $18-$29 billion, that's the one time cost to cure everyone in CA with it) to cure a portion of the population in CA that has Hep C. Most likely we're talking $3-$5 billion per year.
Calculate the savings that curing those people produces over time (1, 5, 10, 20 years).
I'd be willing to bet the math works out in favor of spending $84,000 one time.
Re: How India's Patent Office Destroyed Gilead's Global Game Plan
#43Earlier quoted context omitted.
I don't think companies spend as much as we believe in researching drugs. Companies spend most on advertising and incentivizing the doctors to prescribe their medicines. The book: Bad Pharma [1] is an eye opener. The drug "Sovaldi" is making them $2.8ish billion dollars per quarter, that is almost $12 billion a year. I don't believe they spent tens of billions in developing the drug. [2] 1: http://www.amazon.com/Bad-…
It's not what they spent developing Sovaldi -- it's the fortune the industry as a whole spends developing drugs that never make it to market. That said, it's quite likely true that marketing is a bigger share of costs than R&D. Pharma companies are out there to maximize revenue, just like any other corporation. It's a reflection of the poor state of regulation in the US that we pay far more of than our share (compare…
One reason we pay so much more is that one lawsuit can cost a company billions. In a place like China, good luck suing anyone and actually winning.
Elimination of punitive damages or more importantly making punitive damages excluded from lawyer commissions would be a step in the right direction. Additionally, punitive damages ought not go to the complainant, but to the taxpayer and thus funneled into grants, etc for basic science research to potentially lower the costs of future development. The only person that benefits from a punitive award is the lawyer and the 'victim.' Lawsuits should not be a lottery ticket.
Re: How India's Patent Office Destroyed Gilead's Global Game Plan
#44Here's the decision (pdf): http://freepdfhosting.com/985d1c013c.pdf It relies on section 3(d) of the The Patents Act, 1970 (as amended up to Patents (Amendment) Act, 2005) [1]: > What are not inventions. —The following are not inventions within the meaning of this Act,— (d) the mere discovery of a new form of a known substance which does not result in the enhancement of the known efficacy of that substance or the mer…
Gilead argued that 1) its compound is not a mere "new form" of a substance known in the prior art, and 2) even if it were, it differs significantly since it is less toxic and more active than other similar compounds. But the Patent Office says that "efficacy" here means therapeutic efficacy, and it would need to be proven by a clinical trial.
Not very sure what they mean exactly, but the FDA mandates clinical trials, right? Can that data not be used to show increased efficacy, if any?
Re: How India's Patent Office Destroyed Gilead's Global Game Plan
#45Earlier quoted context omitted.
The article explains it better instead of simply saying it's not innovative. It's worth reading these 2 paragraphs: "India believes that the patent standards are so low that companies can get patents for inventions very easily," Amin said in an interview. The patent office's examiner ruled Gilead's patent claim "lacks novelty and inventive step," as Bloomberg News noted, and also doesn't demonstrate it's significantl…
This is what I think is the vital issue. Taking a known compound and searching for every possible form in order to find one that doesn't happen to have been documented is in fact something that is "obvious to one skilled in the art," because it's a widespread activity. There are specific rules in the US patent system surrounding this issue. So it's not like the drug maker was necessarily whacked by some rogue judge i…
> Taking a known compound and searching for every possible form in order to find one that doesn't happen to have been documented is in fact something that is "obvious to one skilled in the art," because it's a widespread activity.
But it is not the activity (which describes, essentially, most research) being patented, it is the result of that activity. If the search space is very large, that is actually an indication of the non-obviousness of a solution that works in practice. Drug discovery certainly meets that criteria.
Re: How India's Patent Office Destroyed Gilead's Global Game Plan
#46I'm disappointed this article doesn't mention the effect this will have on future pharmaceutical investment. Companies spend billions researching and testing drugs for safety and effectiveness. Companies capable of developing successful drugs need an adequate period in which to recoup their investment and earn enough to fund new drug research. If companies know they won't have meaningful ownership over medicines they…
You don't understand gravity of situation. India has third highest population of AIDS patients. Around 2.1 million people are infected[1]. That is twice the population of Cyprus. Around 170k children and adults lost their lives in 2009 [2]. India has 32.7 % of its population below poverty line [3]. That's an income below $1.25 per day. If they can't pay for the drugs doesn't make them less deserving. And as far as dr…
> And as far as drug developments go, due to GPU computing and molecular dynamics and monte carlo simulation methods, the cost of developing drugs has gone significantly down [4][5].
I don't see where they show that the cost of clinical trials etc. for getting drugs through the FDA is affected. From what I can tell, those are the largest costs involved. Especially considering that most of the drugs discovered, even using those advanced methods, fail in the trial phase after hundreds of millions invested.
> If Government of India thinks more about it's 2.1 million than bunch of corporate companies trying to siphon money from wherever they can, then YES, they are in the right direction.
"Siphon money" or "capture the rewards of the value they provide"? Undermining global incentives to invest billions in research that could save hundreds of millions around the world does not seem like the "right direction". Not the first time the Indian government has done something selfish but shortsighted. (Pokhran comes to mind.)
Re: How India's Patent Office Destroyed Gilead's Global Game Plan
#47Earlier quoted context omitted.
Here's the piece of the picture that everyone's missing from this particular example - an $11b acquisition [1]. Gilead bought Pharmasset for $11b. It no longer matters what it cost Pharmasset to research/test/approve/produce the medicine anymore. Certainly all of that was factored into the acquisition price but since Gilead's total cost ended up being $11b, that is what they need to recoup at the least. There are 3.2…
well that's nice and all, so next time CEO wants a new fleet of jet aircrafts for him, all should pay more for the medicines? Because, you know, we can? Companies should definitely make profit, but their default modus operandi is "milk the cow as long as possible", which would directly result in many deaths... not much sympathy from the crowd there. Let's not forget simple math here - company is/was charging for medi…
> Don't care about research bla-bla
Of course you wouldn't, since that's what costs billions to discover the medication that eventually costs "tens of bucks" to produce, which completely undermines your argument.
Re: How India's Patent Office Destroyed Gilead's Global Game Plan
#48I'm all against "obvious" patents, but suing to be free to produce a product because it "also doesn't demonstrate it's significantly more effective than already known compounds" is a contradiction in terms. If the other compounds were just as good, then you wouldn't be suing to be able to produce this new one.
That logic doesn't always hold up. You could make tiny tiny alterations to some plastic container, put some random bump here or there, or make the flap stick out a little more, and the plastic container might suddenly not be usable due with a third party automatic coffee maker. That's a huge effect, despite the tiny change. But I doubt that would make that case that because of that huge effect, those random bumps and…
I don't see how this addresses grandparent's comment: if it does not have increased efficacy, why are so many people desperate to use it? The amount of alteration is a separate issue.
Re: How India's Patent Office Destroyed Gilead's Global Game Plan
#49Can people in now go to India on medical tourism and get the treatment much cheaper?
This has always been the case [1] :-). Medicines and medical care in India is cheaper, by many folds, compared to US. Anecdotaly, whenever my Indian friends working in US visit India (parents, family) one thing they never forget is to visit dentists. I initially found it very surprising but understood their reasoning when I came to know that in US you can easily go bankrupt due to medical condition, something that's…
>>something that's unheard of in India.
Maybe not if you're in the 'upper middle class'. If you're from the lower income classes (maids, drivers, helpers), it's very likely that health issues can bankrupt you.
I personally know an entire family that has sunk into debt that they couldn't possibly pay-off, due to health related expenses for someone in the family.
Re: How India's Patent Office Destroyed Gilead's Global Game Plan
#50What I don't understand is how this would ease the export of this now-generic drug to other countries.
Surely each of them has a patent office, doesn't it?